Comprehensive Stability Study Protocol for Single-Dose Vials
This protocol outlines the procedures for conducting stability studies on single-dose vials, assessing sterility, potency, and physical stability under different environmental conditions.
| Parameter | Details |
|---|---|
| Product Name | [Single-Dose Vial Product Name] |
| Batch Number | [Batch Number] |
| Objective | To evaluate the stability of the single-dose vial under specified conditions. |
| Test Parameters |
– Sterility – Potency  |
| Storage Conditions | [e.g., 25°C/60% RH] |
| Test Intervals | [Specify intervals: 0, 3, 6 months, etc.] |
| Acceptance Criteria | No significant changes in sterility, potency, or physical appearance. |
| Regulatory Guidelines | ICH Q1A(R2), FDA, EMA |
| Signatories | QA, QC, Regulatory Affairs |